射频消融与激光消融治疗肝硬化小肝细胞癌的随机试验

Radiofrequency ablation versus laser ablation for the treatment of small hepatocellular carcinoma in cirrhosis: a randomized trial.

作者信息

Di Costanzo Giovan Giuseppe, Tortora Raffaella, D'Adamo Giuseppe, De Luca Massimo, Lampasi Filippo, Addario Luigi, Galeota Lanza Alfonso, Picciotto Francesco Paolo, Tartaglione Maria Teresa, Cordone Gabriella, Imparato Michele, Mattera Silvana, Pacella Claudio Maurizio

机构信息

Liver Unit, Cardarelli Hospital, Naples, Italy.

出版信息

J Gastroenterol Hepatol. 2015 Mar;30(3):559-65. doi: 10.1111/jgh.12791.

DOI:10.1111/jgh.12791

PMID:25251043

Abstract

BACKGROUND AND AIM

In patients with cirrhosis and small hepatocellular carcinoma (HCC), thermal ablation is currently recognized as an effective local treatment. Among thermal procedures, radiofrequency ablation (RFA) is the most diffusely used and is the standard against which any new treatment should be compared. In retrospective studies, laser ablation (LA) resulted as safe and effective as RFA. Therefore, we performed a non-inferiority randomized trial comparing RFA with LA in patients with cirrhosis and HCC within Milan criteria.

METHODS

Overall, 140 patients with 157 HCC nodules were randomly assigned to receive RFA or LA. The primary end-point was the proportion of complete tumor ablation (CTA). Secondary end-points were time to local progression (TTLP) and overall survival (OS).

RESULTS

Per patient CTA rates after RFA and LA were 97.4% (95% CI, 91.0-99.3) and 95.7% (88.1-98.5), respectively (difference = 1.4%, 95% CI from -6.0% to + 9.0%). Per nodule CTA rates for RFA and LA were 97.4% (91.0-99.3) and 96.3% (89.6-98.7), respectively (difference = 1.1%, from -5.7% to + 8.1%). The mean TTLP was comparable between RFA group (42.0 months; 95% CI, 36.83-47.3) and LA group (46.7 months; 95% CI, 41.5-51.9) (P = .591). The mean OS was 42 months in both groups and survival probability at 1 and 3 years was 94% and 89% in RFA group, and 94% and 80% in LA group.

CONCLUSION

LA resulted not inferior to RFA in inducing the CTA of HCC nodules and therefore it should be considered as an evaluable alternative for thermal ablation of small HCC in cirrhotic patients.

摘要

背景与目的

在肝硬化合并小肝细胞癌（HCC）患者中，热消融目前被认为是一种有效的局部治疗方法。在各种热消融治疗中，射频消融（RFA）应用最为广泛，是任何新治疗方法都应与之比较的标准。回顾性研究表明，激光消融（LA）与RFA一样安全有效。因此，我们进行了一项非劣效性随机试验，比较RFA与LA治疗符合米兰标准的肝硬化合并HCC患者的疗效。

方法

总共140例患有157个HCC结节的患者被随机分配接受RFA或LA治疗。主要终点是完全肿瘤消融（CTA）的比例。次要终点是局部进展时间（TTLP）和总生存期（OS）。

结果

RFA组和LA组患者的CTA率分别为97.4%（95%CI，91.0 - 99.3）和95.7%（88.1 - 98.5）（差异 = 1.4%，95%CI为 - 6.0%至 + 9.0%）。RFA组和LA组结节的CTA率分别为97.4%（91.0 - 99.3）和96.3%（89.6 - 98.7）（差异 = 1.1%，范围为 - 5.7%至 + 8.1%）。RFA组（42.0个月；95%CI，36.83 - 47.3）和LA组（46.7个月；95%CI，41.5 - 51.9）的平均TTLP相当（P = 0.591）。两组的平均OS均为42个月，RFA组1年和3年的生存概率分别为94%和89%，LA组为94%和80%。